FDA.reportPublic FDA data

Zimmer Biomet™

Primary DI
00889024355231
Brand
Zimmer Biomet™
Company
Zimmer Surgical SA
Model
89-8510-459-46
Catalog number
89-8510-459-46
Published
2016-05-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FSMTray, Surgical, Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889024355231PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024355231008890243552318890243552310889024355231

GMDN Terms#

Term, Definition table
TermDefinition
Sterilization/disinfection containerA receptacle designed to hold wrapped and/or unwrapped medical devices in a chemical washer/disinfector and/or sterilizer during the washing/disinfection and/or sterilization cycle(s). It may be designed as a tray to allow full or partial immersion of the devices in a liquid disinfectant, or as an enclosed box to prevent contamination once the sterilization process is finished. The container may also be used for transport and storage of the processed devices, and may have features such as an expiry date label, breathing filter, built-in slots for microsurgical instruments, and stacking capabilities. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
1(800)348-2759zimmer.consumerrelations@zimmer.com
+1(800)348-2759zimmer.consumerrelations@zimmerbiomet.com

Regulatory Flags#

DUNS number
481290781
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889024687462Zimmer Biomet®1100462981100462982025-04-01
00889024355163Zimmer Biomet™89-8510-440-3089-8510-440-302022-06-10
00889024581746Zimmer Biomet™89-8521-470-4089-8521-470-402020-09-03
00889024355149Zimmer Biomet™89-8510-440-1089-8510-440-102016-05-16
00889024521117Zimmer Biomet™ X Series Power System8985204000089-8520-400-002020-09-03
00889024521124Zimmer Biomet™ X Series Power System8985204001089-8520-400-102020-09-03
00889024354593Zimmer® Universal Power System8985074000089-8507-400-002016-05-16
00889024354609Zimmer® Universal Power System8985074001089-8507-400-102016-05-16
00889024581760Zimmer Biomet™89-8521-470-8089-8521-470-802022-12-16
00887868572890Zimmer Biomet®89-8522-150-7089-8522-150-702023-09-28
00887868572906Zimmer Biomet®89-8522-270-7089-8522-270-702023-09-28
00887868572913Zimmer Biomet®89-8522-600-7089-8522-600-702023-09-28
00889024521100Zimmer Biomet™89-8521-470-7089-8521-470-702022-12-16
00889024490109Zimmer Biomet™89-8509-451-4689-8509-451-462022-06-10
00889024521339Zimmer Biomet™89-8522-451-4289-8522-451-422020-09-03
00889024521346Zimmer Biomet™89-8522-451-4389-8522-451-432020-09-03
00889024354951Zimmer Biomet™89-8509-451-4189-8509-451-412016-05-16
00889024421530Zimmer Biomet™89-8509-451-4289-8509-451-422016-05-16
00889024421547Zimmer Biomet™89-8509-451-4389-8509-451-432016-05-16
00889024581722Zimmer Biomet™89-8521-470-2089-8521-470-202020-09-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00196449010134Anatomic Access LLIFTyber Medical, LLCFSM2026-06-09
00196449035489Anatomic Access LLIFTyber Medical, LLCFSM2026-06-09
00196449035496Anatomic Access LLIFTyber Medical, LLCFSM2026-06-09
00196449035502Anatomic Access LLIFTyber Medical, LLCFSM2026-06-09
00196449035519Anatomic Access LLIFTyber Medical, LLCFSM2026-06-09
00196449035526Anatomic Access LLIFTyber Medical, LLCFSM2026-06-09
00889024701670Identity® Shoulder SystemZimmer, Inc.FSM2026-06-09
04251047924804Sterilizing CaseA1 Medical GmbHFSM2026-06-09
04251047926389Sterilization Tray with LidA1 Medical GmbHFSM2026-06-09
04251047930386Double-level Sterilization TrayA1 Medical GmbHFSM2026-06-09
00810055257874Surgical DesignSurgical Design, Inc.FSM2026-06-06
00810055257881Surgical DesignSurgical Design, Inc.FSM2026-06-06
00810055257898Surgical DesignSurgical Design, Inc.FSM2026-06-06
00810055257904Surgical DesignSurgical Design, Inc.FSM2026-06-06
00810055257911Surgical DesignSurgical Design, Inc.FSM2026-06-06
00810055257928Surgical DesignSurgical Design, Inc.FSM2026-06-06
00810055257935Surgical DesignSurgical Design, Inc.FSM2026-06-06
00810055257942Surgical DesignSurgical Design, Inc.FSM2026-06-06
00857915007750Endo ECTR TrayA.M. SURGICAL, INC.FSM2026-06-04
10705037042999STERRAD™ADVANCED STERILIZATION PRODUCTS SERVICES INC.FSM2026-06-03
07613327605716PANGEAStryker GmbHFSM2026-06-02
07613327623260MakoMAKO SURGICAL CORP.FSM2026-05-29
08435389830207STOP & GUIDE® BOXBIOTECHNOLOGY INSTITUTE SLFSM2026-05-27
08435389830962DRILL HOLDER FOR EXTRA SHORT DRILLSBIOTECHNOLOGY INSTITUTE SLFSM2026-05-27
07630055307736ACE Acetabular Reamer Tray - Instrument TrayIncipio Devices SAFSM2026-04-30
07613327652765TPXSTRYKER CORPORATIONFSM2026-03-25
07613327631852RPSSTRYKER CORPORATIONFSM2025-10-10
07613327631869RPSSTRYKER CORPORATIONFSM2025-10-10
07613327631876RPSSTRYKER CORPORATIONFSM2025-10-01
07613327681741N/ASTRYKER CORPORATIONFSM2025-09-03